Device for collection of uncontaminated urine from children

ABSTRACT

A disposable device for collection of uncontaminated urine samples from small children comprising a sterile container with an inlet that eliminates direct contact between the wearers skin and the inside of the container, and which is initially closed by a delaying mechanism consisting of, e.g. a water soluble adhesive substance or material. The flow to the container is initially hindered by said delaying mechanism located in the inlet of the container. This causes the initial portion of fluid, which may be contaminated with bacteria, to be absorbed by an absorbing layer whereafter the inlet is automatically opened so that the remaining fluid can reach the container essentially uncontaminated.

PRIOR APPLICATIONS

This §371 National Phase patent application bases priority onInternational Application No. PCT/SE2003/001238, filed on Jul. 24, 2003,which in turn bases priority on Swedish Application No. SE 0202330-7,filed on Jul. 29, 2002.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a device used for collection ofuncontaminated urine samples from small children.

2. Description of the Prior Art

Infection of the urinary tract is a relatively common and potentiallyserious disease, especially in children. Urinary tract infection isdiagnosed by demonstrating growth of bacteria in the urine. Crucial forthe reliability of such analysis is that the enteric bacteria thatnormally colonize the skin of the uro genital area do not contaminatethe urine sample. The most reliable ways to obtain an uncontaminatedurine sample is by percutaneous bladder tap, urethral catheterization orby midstream specimen. These methods are, however, in many cases notsuitable. Percutaneous bladder taps, as well as urethralcatheterization, are proportionately traumatic procedures and midstreamspecimens are for practical reasons difficult to obtain, above all fromsmall children since they usually are not able to produce a urine sampleon demand. Ordinarily, a collecting bag attached to the genital area istherefore used. This allows the children to move around and does notimply any significant discomfort to them.

The collecting devices that are currently used are designed as a plasticbag. It has an opening on one side that is attached to the genital areawith an adhesive material.

Examples of such devices can be found in patents GB 1051875, WO 0000111,SE 333792, U.S. Pat. No. 3,406,690, U.S. Pat. No. 3,523,537, and U.S.Pat. No. 3,200,415. Alternative designs are presented in U.S. Pat. No.3,918,433 and GB 2163656. Common to the mentioned patents is, however,that they mainly focus on the attachment and collection functions of thedevice and that they do not address the risk of contamination.sufficiently. Other patents that address this problem can be found inU.S. Pat. No. 4,557,274, U.S. Pat. No. 4,492,258, and U.S. Pat. No.3,881,465.

Using the above mentioned devices, a substantial part of the samples isrendered useless and has to be resampled since they have beencontaminated with non-relevant bacteria. This leads to delay anddifficulties in diagnosing and treatment, yielding over, as well asunder, diagnosing the consequences, being apart from higher costs andineffective use of medical care resources, unnecessary suffering for thepatients and their parents.

SUMMARY OF THE INVENTION

The purpose of the invention is to mainly create a disposable devicethat solves the problem with bacterial contamination when collectingurine samples from children. The device should furthermore be easy touse and be manufacturable at a cost that does not substantially exceedthe manufacturing cost of the products used today.

When using conventional devices, the main contamination occurs when thefluid on its way to the container collects non-relevant bacteria, partlydirectly from the skin, partly from those parts of the collecting devicethat have been in direct contact with it.

In order to avoid this, the present invention is furnished with acollecting bag whose opening excludes all direct contact between theskin and the inner face of the collecting bag. The opening is,furthermore, initially sealed with, for example, a water solubleadhesive material or substance. In the moment of voiding, this isdissolved by the fluid so that the inlet of the collecting bag opens.The fluid that initially is prevented from reaching the collecting bagis almost instantly absorbed by the absorbing material.

This design renders a rinsing effect of those surfaces that the initialfluid is exposed to, simultaneously preventing non-relevant bacteriabeing flushed along from reaching the collecting bag.

BRIEF DESCRIPTION OF THE DRAWINGS

Further advantages and features of the present invention can be gatheredfrom the following description of the preferred embodiment relative tothe attached drawings, wherein:

FIG. 1 is a front perspective view of a first embodiment of the devicefor collection of uncontaminated urine from a child;

FIG. 2 is a side view of the embodiment shown in FIG. 1;

FIG. 3 shows the embodiment of FIG. 1 in an unfolded position prior towelding; and

FIG. 4 is a side view of a second alternate embodiment of the device forcollection of uncontaminated urine from a child.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

All figures and descriptions relate to the user point of view. Theexpression “from above” means consequently the side the user sees fromabove, that is the side that, when in use, is attached to the body.

The expression “uncontaminated” here means a contamination with bacteriathat is significantly below the lower value for significant bacteriuriaapplied to this kind of urine analysis.

The invention consists of a collection bag 1 with an absorbing material7 placed around an opening 4 on the upper face of the device. The deviceis worn with the absorbing layer 7 against the body, placed so that saidopening 4 is situated opposite to the urethral opening. Fluid reachesthe collecting bag 1 via said opening 4, whereafter it passes atube-shaped channel 5 initially closed by a delay mechanism 9 consistingof, for example, a water soluble adhesive material or substance 9. Whenthe urine reaches said opening 4, instant flow to the collecting bag 1is prevented due to the adhesive substance 9 placed in the channel 5,whereby the fluid is absorbed by the absorbing material along with amajor part of the bacteria that have contaminated the transport route ofthe fluid. Thereafter, the adhesive substance 9 is dissolved so thatsaid channel 5 is opened, whereafter the remaining fluid is able toreach the collecting bag 1, mainly uncontaminated.

According to the first embodiment shown in FIGS. 1-3, the device isshaped as a bag similar to the bags used today. According to saidsuggestion, it can be manufactured from a single piece of plastic sheetmaterial (see FIG. 3). When the opening 4 has been made and the delaymechanism 9 has been positioned on its intended place, the work piece isfolded in two places 10 and welded together 11, according to FIG. 3.Thereafter, the absorbing layer 7 and the adhesive surface 8 is mounted.

According to the second alternate embodiment shown in FIG. 4, thecontainer of the device 1 is attached to the lower side of yet anotherlayer 12. This layer can, for example, be in the form of a diaper, andits main purpose is to function as an alternative attachment device forthe container. Said layer 12 has, in this case, been equipped with thosedetails and functions which were placed directly on the upper side ofthe container in the previous suggestion.

The device comprises a container 1 with sufficient volume to be able tocontain the appropriate amount of urine. The container can, for example,be rectangular, oval or anatomically shaped. It can be manufactured fromone or several pieces of material. Said container 1 can, for example, bemade of a fluid impermeable plastic film made of a thermoplasticmaterial like polyethylene or polypropylene. The container 1 can bewelded, glued or otherwise assembled in any other way known to humanity.

The inlet of the container 1 starts with an opening 4 in a layer ofplastic material 2 that has been attached to a lower layer 3 so that atube like channel 5 is formed. These layers can be made from the samework piece as the container, according to the first embodiment (seeFIGS. 1-3), or from two different pieces, according to the secondalternate embodiment (see FIG. 4).

The opening 4 is situated at the most appropriate place of the devicedepending on the design and should be designed so that it facilitatesthe opening of said channel 5. It should be as small as possible becauseof the risk of contamination, yet large enough to render a correctplacement of the device when applied to the body. Said channel 5 can beof different sizes and can be located anywhere within said opening 4.

The aperture of the container consists of said channel 5 which entranceconsists of a funnel-shaped flange 6. This flange should be designed sothat is leads the fluid towards said channel 5 without preventing theinitial part of the fluid from reaching the absorbing layer 7. Onepossible design is presented in FIGS. 1-3, where the upper plastic layer2 has been attached 11 to the lower layer 3, so that the flange extendsaround the opening 4 to its opposite side where the lower layer 3 hasbeen attached to the outer rim of the upper layer 2.

The channel 5 is initially closed in a way that enables it to openautomatically, shortly after coming in contact with the fluid. Such adelaying mechanism 9 could be accomplished with a suitable water solublesubstance or material that dissolves within a specified time frame. Thissubstance or material can consist of glue, an adhesive polymer or anyother known substance or material with preferred characteristics. Itshould, however, not contain any substances that affect the quality ofthe sample in any significant way.

On the upper side of the container 1, an absorbing layer 7 is placedclose to the opening 4. This material could, e.g. consist of cellulosefibers, viscose fibers or super absorbing synthetic polymers such aspolyacrylate. The layer can be designed in any form, for example, round,oval or rectangular, and should be placed where it best serves itsfunction.

It can also be designed according to gender and equipped withanatomically-shaped contour to enhance fitting. The material should bechosen and designed so that a certain amount of fluid is absorbed withina predefined time frame. It can also be surrounded by a waterproofbarrier to prevent too much fluid from being absorbed or reach theadhesive surface 8 that attaches the device to the body. This barriercan, for example, be manufactured from a surface treated, non-wovenmaterial or from any other suitable material.

The absorbing layer 7 can be covered with a surface layer that onlypermits fluid to flow in one direction, so that the already absorbedfluid is prevented from leaking back, and thereby reaching thecontainer. This layer can consist of any known appropriate materialavailable on the market, and can, for example, consist of a non-wovenmaterial that has been surface treated, laminated or prepared in anyother way, and thereby achieve preferred characteristics.

The device can also be provided with one or several adhesive surfaces 8partly to keep the device in place, partly to prevent leakage. Theadhesive surfaces 8 can consist of any waterproof adhesive substance ofthose commonly used in this context. Especially suitable are those ofhydrocolloid or hydrogel type. The surfaces can be of any shape andnumber, and can be placed anywhere on the device. The surfaces can besupplied with a protective sheet that can be removed before use.

1-7. (canceled)
 8. A disposable device for collection of anuncontaminated urine sample from a small child, comprising: a sterilecontainer attached to a uro genital part of the child, an inlet to thecontainer initially closed by a delaying mechanism, the delayingmechanism automatically opening the inlet within a predetermined amountof time after the inlet is reached by urine and thereby preventing afirst portion of the urine from reaching the container, the firstportion of the urine absorbed by an absorbent material placed around theurine path from the uro genital part to the inlet, and the inlet havinga channel for eliminating direct contact between a skin surface of thechild and the inside of the container.
 9. A disposable device accordingto claim 8, wherein the delaying mechanism is a water soluble adhesiveadapted to dissolve on contact with the urine.
 10. A disposable deviceaccording to claim 8, wherein the absorbent material is covered by alayer of material adapted to allow the urine to flow through in onedirection.
 11. A disposable device according to claim 8, wherein theabsorbing material is surrounded by a waterproof barrier for preventingover absorption of the area.
 12. A disposable device according to claim8, wherein the absorbing material has an anatomically-shaped contour tofit wearers of both sexes.
 13. A disposable device according to claim 8,wherein the device has at least one adhesive surface for securing thedevice to the uro genital part of the child.
 14. A disposable deviceaccording to claim 8, wherein the container is attached to a diaper. 15.A disposable device according to claim 8, wherein the inlet to thechannel is a funnel-shaped flange.